JPRN-jRCT2061230065进行中（未招募）2 期
Phase II clinical study of TR-012001 in Japanese patients with Parkinson's disease
Kanazashi Shuichi0 个研究点目标入组 12 人开始时间: 2023年10月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Japanese males and females aged 30 years or older at the time of informed consent.
- •(2) Patients diagnosed with idiopathic Parkinson's disease according to the UKPDS Brain Bank Parkinson's disease diagnostic criteria.
- •(3) Patients with Parkinson's disease stage 2-4 on the revised Hoehn & Yahr grading system in the on state.
- •(4) Patients who are taking levodopa-containing formulations* three times or more per day, with a daily dosage of 300 mg or more of levodopa.
- •*Levodopa-containing preparations: Levodopa/dopa decarboxylase inhibitor (DCI) combination preparations, DCI can be either carbidopa or benserazide.
- •(5) Patients who can maintain a fixed dosage and administration of levodopa-containing preparations and other antiparkinsonian drugs (only for patients taking medication) after obtaining informed consent until the end of the study.
- •(6) Patients who are found to be off in their daily life by patient evaluation.
- •(7) Females of childbearing potential* or males with female partners of childbearing potential* who agree to practice adequate contraception on a daily basis from the time consent is obtained until the end of the study.
- •* Female (partners) of childbearing potential: Women who have not confirmed menopause (no menstruation for 52 weeks or more counting from the start of the last menstrual period).
- •(8) Patients who are fully informed about the purpose and contents of this study before the start of screening, who understand the contents of the informed consent form, and who can sign their own will.
排除标准
- •(1) Patients with non-idiopathic Parkinson's disease [atypical Parkinson's disease, secondary (acquired or symptomatic) Parkinson's disease, Parkinson's plus syndrome, etc.].
- •(2) Patients with hypersensitivity or allergy to the API or other ingredients used in the investigational drug, or patients with a history of severe allergy to other drugs (anaphylaxis, etc.).
- •(3) Patients with angle-closure glaucoma.
- •(4) Patients with disease or findings that are judged to affect this study from the viewpoint of safety and/or evaluation.
- •(5) Patients who received levodopa continuous enteral therapy (LCIG therapy: Levodopa-carbidopa continuous infusion gel treatment) or patients who plan to receive it during the study period.
- •(6) Patients who have used Apokyne subcutaneous injection 30 mg within 1 month prior to obtaining informed consent or patients who plan to use Apokyne during the study period.
- •(7) Patients who have undergone brain surgery for Parkinson's disease (pallidotomy, deep brain stimulation, etc.) or patients who plan to undergo such surgery during the study period.
- •(8) Patients who received or plan to receive transcranial magnetic stimulation therapy within 6 months prior to consent.
- •(9) Patients with a history or comorbidities of drug abuse or alcoholism.
- •(10) Patients with a history or complication of mental illness (schizophrenia, psychotic depression, etc.). However, psychiatric symptoms associated with Parkinson's disease are excluded.
- •(11) Patients with overt dementia or Mini-Mental State Examination (MMSE) score less than 24 points.
- •(12) Patients with a history of suicidal ideation or attempted suicide within the past year or a history of present illness.
- •(13) Patients with a history of malignant syndrome caused by antiparkinsonian drugs.
- •(14) Patients with clinically problematic brain, cardiovascular, hematological, autoimmune, endocrine, cardiovascular, renal, gastrointestinal, or respiratory diseases (including infectious diseases) that are judged by the investigator to have the potential to affect the conduct of this study from the perspective of safety and other factors.
- •(15) Patients with any of the following laboratory test results from screening tests:
- •- A creatinine level greater than or equal to 2x the laboratory upper limit
- •- Total bilirubin level greater than or equal to 3 times the laboratory upper limit
- •- ALT or AST greater than or equal to 3 times the laboratory upper limit
- •- ALP greater than or equal to 3 times the laboratory upper limit
- •(16) Patients who have clinically significant abnormalities in other tests (including clinical tests) in the screening test and are judged by the investigator to be inappropriate for participation in this study.
- •(17) Patients with acquired immunodeficiency syndrome (AIDS) (including patients who are either HIV antigen or antibody positive) or hepatitis (including patients who are HBs antigen positive or HCV antibody positive).
- •(18) Patients who required treatment for malignant tumors within 5 years before consent was obtained (excluding treated cervical intraepithelial neoplasia, cured nonmetastatic squamous or basal cell tumors of the skin).
- •(19) Patients who are scheduled for surgery requiring hospitalization during the study period or who are in a condition requiring surgery.
- •(20) Patients who are pregnant, breastfeeding, may be pregnant, or wish to become pregnant during the study period.
- •(21) Patients who have received all other unapproved drugs (including investigatio
研究者
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